MIST (Metabolic Intervention With Semaglutide and THR-β Therapy) Trial

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Adult Obesity, Weight Management

In brief

The primary objective of this trial is to evaluate the effect of oral ECC4703 on body weight reduction and in a sub-study on liver fat content as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 20.

Key facts

Study ID

NCT07505303

Run by

Eccogene

People needed

151

Starts

2026-03-23

Expected to finish

2026-10-15

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Capable of providing written informed consent and complying with all trial procedures.
• Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
• Obese with BMI ≥30 kg/m\^2 and stable body weight within 6 months prior to screening.
• HbA1c ≤6.5%.
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 (per CKD-EPI 2021 formula).
• If participant consents to enter the imaging substudy, has liver fat content by MRI-PDFF >8% at baseline (Week 9).

You may not qualify if…

• History or current diagnosis of type 1 or type 2 diabetes mellitus.
• Weight change >5% of total body weight within 6 months prior to screening or planned initiation of a weight loss program or use of weight-altering medication.
• Obesity induced by endocrine disorders such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
• Use of GLP-1 agonist treatment within the last 6 months prior to screening.
• History or current evidence of a pituitary disorder.
• Have current treatment with or history (within 3 months prior to screening) of treatment with medications that may cause significant weight gain.
• ALT or AST >1.5×ULN, or ALP >1.5×ULN at screening.
• Documented evidence or clinical signs/symptoms of advanced liver disease including liver cirrhosis, portal hypertension, or hepatic decompensation.
• History of significant alcohol consumption for >3 consecutive months within a year prior to screening.
• Current or past therapy with THR-β agonists (eg, resmetirom).
• Active untreated hyperthyroidism or hyperthyroidism currently treated with antithyroid medications including methimazole or propylthiouracil.
• Clinically significant thyroid dysfunction including uncontrolled hypothyroidism or hyperthyroidism.
• History of bariatric surgery, fitting of a weight loss device, or intestinal bypass surgery within 5 years prior to screening.
• History of major surgery within 8 weeks prior to screening.
• Clinically relevant acute or chronic medical condition or unstable disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic system.

Where it is running

• Central Research Associates - Flourish - PPDS — Birmingham, Alabama, United States
• Anaheim Clinical Trials LLC - Anaheim - CenExel - PPDS — Anaheim, California, United States
• Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS — Los Alamitos, California, United States
• AES - DRS - Optimal Research Florida - Melbourne — Melbourne, Florida, United States
• ForCare Clinical Research - CenExel FCR - PPDS — Tampa, Florida, United States
• Atlanta Center for Medical Research - CenExel ACMR - PPDS — Atlanta, Georgia, United States
• iResearch Atlanta - CenExel - PPDS — Decatur, Georgia, United States
• AES - DRS - Synexus Clinical Research US, Inc. - Richfield - Minneapolis — Richfield, Minnesota, United States
• Velocity Clinical Research (3345 N 107th St) - Omaha - Nebraska - PPDS — Omaha, Nebraska, United States
• Velocity Clinical Research - Durham - PPDS — Durham, North Carolina, United States
• Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS — Cincinnati, Ohio, United States
• Velocity Clinical Research - Providence - PPDS — East Greenwich, Rhode Island, United States
• Velocity Clinical Research - Dallas - PPDS — Dallas, Texas, United States
• AES - DRS - Synexus Clinical Research US, Inc. - San Antonio — San Antonio, Texas, United States
• Flourish Research - San Antonio - PPDS — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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